Clinical Trial Podcasthttp://clinicaltrialpodcast.com
Expert Insights for Clinical Research ProfessionalsWed, 16 Aug 2017 20:49:47 +0000en-UShourly1https://wordpress.org/?v=4.8.1CTP 002: Hidden Opportunities in Clinical Research with Gary Thompsonhttp://clinicaltrialpodcast.com/interview-gary-thompson/
http://clinicaltrialpodcast.com/interview-gary-thompson/#respondWed, 16 Aug 2017 20:44:33 +0000http://clinicaltrialpodcast.com/?p=368“Life is an adventure” – Gary Thompson In this interview, I had the pleasure to speak with one of the most optimistic individuals on the planet, Gary Thompson. Gary is the Vice President of Clinical Research at Abbott Vascular. In this interview, Gary shares a ton of valuable information on...

In this interview, I had the pleasure to speak with one of the most optimistic individuals on the planet, Gary Thompson.

Gary is the Vice President of Clinical Research at Abbott Vascular. In this interview, Gary shares a ton of valuable information on career choices, his #1 advice for all managers, and the relationship between money and happiness.

In his free time, Gary loves to sail and is a proud owner of two sailboats. We discuss how sailing and clinical research are related in more ways than you can imagine.

]]>http://clinicaltrialpodcast.com/interview-gary-thompson/feed/0CTP 001: Becoming an Intelligent Clinical Researcher with David Rutledgehttp://clinicaltrialpodcast.com/interview-david-rutledge/
http://clinicaltrialpodcast.com/interview-david-rutledge/#respondSun, 13 Aug 2017 18:00:49 +0000http://clinicaltrialpodcast.com/?p=246In this episode, David and I talk about his work in quality, clinical and regulatory affairs. We dig deep into his academic and industry roles, his experience in China and importance of continuous learning.

“It’s important to make things clear and also look at it from the lens of public health not just from the lens of business.” – David Rutledge

“Don’t let the place you begin dictate the place you end up” – David Rutledge

My guest on today’s podcast is David Rutledge. David is a Regulatory Affairs Director at Abbott Vascular.

David is an expert in Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER) which form the foundation of medical product approvals and license renewals worldwide.

In his previous role as a Clinical Research Director, David has led publications strategy for Abbott’s medical products including the blockbuster XIENCE V drug eluting stent. David has also served on the FDA advisory committee for four years prior his industry experience.

David is my go-to person for advice on interpretation of Meddev regulations and the Medical Device Regulation (MDR). He is also a regulatory and quality expert presenting at many conferences and providing input on draft regulatory guidance documents.

Enjoy my interview with David!

Selected Links from the Episode:

CFDA demonstrates the wisdom of Confucius. He said, “By three methods we may learn wisdom: First, by reflection, which is noblest; Second, by imitation, which is easiest; and third by experience, which is the hardest.”

]]>http://clinicaltrialpodcast.com/interview-david-rutledge/feed/0Who’s Who In Clinical Researchhttp://clinicaltrialpodcast.com/clinical-research/
http://clinicaltrialpodcast.com/clinical-research/#commentsThu, 20 Apr 2017 18:00:36 +0000http://clinicaltrialpodcast.com/?p=323Who’s Who In Clinical Research Almost everyone I’ve met in clinical research has accidentally discovered this hidden profession. Your interest in science and medicine somehow got you involved in clinical research and clinical trial management. But didn’t you wish you had a crystal clear understanding of “Who’s Who In Clinical...

Who’s Who In Clinical Research

Almost everyone I’ve met in clinical research has accidentally discovered this hidden profession. Your interest in science and medicine somehow got you involved in clinical research and clinical trial management. But didn’t you wish you had a crystal clear understanding of “Who’s Who In Clinical Research?”

That’s when this post come handy.

Clinical Research is sometimes also referred as Medical Affairs or Clinical Affairs. Aside from the naming nuances, the pillars of clinical research remain the same. This is true for pharmaceuticals, medical devices and biologics.

In this article, you’ll learn the functional areas that form an ideal clinical research team at a sponsor or clinical research organization (CRO). For each function, I’ve highlighted why the group exists and their general mindset.

We’ll wrap up our discussion with adjacent departments that interact with clinical research professionals.

So let’s get started:

Project Management

I wanted start with my personal favorite clinical research function, Project Management. The reason why project management team is so interesting is because it provides an holistic view of clinical trial management and clinical research.

“General Contractor” for the study

The project management team is made up of Clinical Project Managers and Program Managers. In some companies, Clinical Project Managers (CPM) may be referred to as Clinical Trial Managers (CTM) or Study Managers.

Project managers are the “General Contractors” of clinical research. They are accountable of all aspects of a clinical trial.

Go-to person for budget, timelines, resources

Developing and actively managing clinical trial finances, timelines and resource allocation is a necessary for a smooth trial execution. This responsibility falls under the project management team.

After mapping out trial assumptions such as number of sites, patients, enrollment period, monitoring, a project manager will develop the study budget and timeline with key milestones.

Depending on the size and reporting structure of the company, project resources are either managed by the project manager or by functional managers.

Ability to connect the dots

A great project manager is able to connect two seemingly unrelated issues and assess the impact on the project.

Let me give you an example.

Say you’re in the midst of a securing FDA approval to start a new clinical trial. You find out that the FDA has follow-up questions. This is going delay the First Patient In (FPI) date. Your investigational devices with limited shelf-life are ready to be shipped to the sites.

A great PM will recognize the downstream effects of study startup delays. For example, she’ll start planning for the additional devices. Not only that but the PM will also adjust the study budget.

Anticipates issues

In addition to be able to connect the dots, a project manager also anticipates issues.

For instance, a clinical site may be enrolling at a rapid pace. During a periodic data review meeting, the project manager finds out that the site has significant number of protocol deviations.

Rather than letting the clinical site continue enrollment, the PM decides to put the site enrollment on hold until the compliance issues are fully addressed and resolved.

The PM anticipates the negative impact of compliance issues on the overall trial. If the PM does not anticipate the issue, it could have negative consequences on the final results and major audit findings for both the sponsor and the clinical site.

Can visualize and paint the big picture

A clinical trial has many moving parts. The objective of most trials is secure product approval, indication approval or assess the long term safety of the product after it is approved.

Keeping this end goal in mind, clinical project manager needs to have a thorough understanding of the key milestones. If challenges arise (which they will), the project manager needs to communicate the challenges effectively to the right stakeholders.

It is also not uncommon for a project manager to paint the big picture for the team. This is necessary to prevent the team from digressing on irrelevant topics or getting distracted.

Not afraid to get hands dirty

When I started my career, I felt that project manager’s primary job was to tell other people what to do and by when it needs to be done.

That certainly did not turn out to be true.

Most of us desire a “perfect” project with no issues or challenges. This is however not reality. There will be obstacles along the way that a project manager will need to overcome.

For example, let’s consider a clinical site that urgently needs investigational devices to enroll a patient the next morning. Unfortunately the FedEx package drop-off time is 4:00pm and the pick-up truck has left for the day. The only way to get the device to the site in time for the procedure is to drop off the device package to the airport. A great project manager would drive to the airport and drop off that package.

There are countless such scenarios where the project manager would need to roll up the sleeves and get to work.

Operations – In-house

Depending on the organization structure, Operations may be rolled up into Project Management or be a separate function.

Operations may be further subdivided in Internal Operations and External Operations. Members of the operations team usually have titles such as clinical research associate or clinical research manager.

Champions site start-up

In-house operations team is primarily responsible for site start-up. This team ensures that each site has the most recent version of the site start-up packet. The start-up packet consists of the protocol, ICF template, and other study specific documents.

The in-house operations team also facilitates clinical contract negotiation with the site, which includes the study budget.

Understands devil is in the details

Once the study-specific ICF template is sent the sites, the sites personnel review and edit the ICF to meet their site-specific IRB/ Ethics Committee requirements. The redlined ICF is then sent to the in-house operations team for final review and approval.

Similar to the ICF redlines, the CRAs also receive redlines on the clinical contracts.

This means that in-house operations is constantly inundated with multiple documents and redlines. This requires the in-house team to be detailed oriented and organized. An error can have significant ramifications including potential audit findings or lawsuits.

Life revolves site management and support

The in-house operations team is available for site management and support. Aside from ICF and clinical contract questions, it usual for sites to contact their in-house CRA with questions about clinical protocol, study specific requirements, investigational device re-stocking, and more.

Operations – Field

A field operations team is composed of field clinical research associate’s (CRA) and clinical research managers. Field CRAs are also known as monitors.

In-house operations and field operations roles can sometimes overlap. In some organizations, field and in-house operations teams are combined into one group, namely Clinical Operations.

Face of the study for clinical sites

A field team is the “face of a study” for a clinical site. Most field operation team members work remotely from their home office. They travel to clinical sites on a regular basis for monitoring and site support.

The field CRA is also responsible for conducting pre-study visits, site initiation visits and study close-out visits.

Understands devil is in the details

A field CRA is responsible for monitoring clinical trial data at the site. A field CRA needs to have thorough understanding of the study protocol, Good Clinical Practice (GCP) and regulations applicable to the conduct of clinical trials.

A clinical trial database has numerous fields. Depending on the monitoring plan, a CRA needs to review and verify the accuracy of the source data at the site.

For example, the CRA ensures the patient informed consent was signed prior to the procedure, serious adverse events were reported on time or protocol deviations were addressed appropriately. This work requires attention to details and deep focus to be done right.

Helps site succeed on all fronts – start-up, enrollment, compliance

Site coordinators can get overwhelmed with multiple trials. Many clinical sites are also nonprofit organization with limited funding and resources to support clinical research.

A field CRA can help their clinical site be successful by promptly answering all questions during study start-up, enrollment and follow-up.

In addition, it’s not uncommon for a CRA to prep sites prior to any scheduled audits.

The job of the field CRA is not “police” the site but rather be the site’s champion and help a site be successful in their research efforts.

Data Management

Here’s the deal.

Products are brought to market based on clinical data. Government agencies, medical community and patients believe in the power of data.

It is no easy task to collect and clean hundreds of clinical trial data points in a compliant manner. This is where the data management team comes to play.

Figures out how data will be collected and cleaned

One of the key responsibility of a data manager is to develop case report forms (CRF) for the collection of clinical trial data. These days most data is collected via electronic data capture (EDC) forms.

A well-designed and thought out CRF can be of great value to the sponsor in the long run. For example, data collected in a case report form can not only help secure product or indication approvals but also forms the basis of publications and presentations.

Life revolves around database locks

Once all patients have completed their primary endpoint visit and the data has been cleaned, the final step is to lock the database.

Database lock is a very important milestone not only for data management but also for the entire organization.

Database locks can be a very stressful time for data managers, sites and CRAs. The CRAs are frantically working with the clinical sites to resolve open queries. A database is usually not locked till open queries are resolved.

Once the database lock occurs, the biostatistics is able to analyze the data and generate tables and graphs.

Communicates data metrics

Without data metrics, you would have no way of knowing whether your sites are completing the CRFs in a timely manner.

Let’s consider a 1000 patient clinical study at 65 sites with 3-year patient follow-up. For each patient there are 20-30 case report forms with multiple fields in each form. It becomes increasingly complex to determine what data is missing, incorrectly entered or not available.

A data management team can create custom reports that can provide data metrics by site, by visit or by patient. This information makes it efficient for sites and CRAs to address data entry gaps and query resolution.

Biostatistics

Statisticians are the numerical brain behind a clinical study. Statistics is a very broad field with numerous data analysis methods.

Key driver behind trial design

One of the key components of clinical trial design is the sample size. Simply speaking, you want to know how many patients are needed in order for the clinical study to be statistically sound.

For many studies, regulatory agencies review the statistical analysis plan (SAP) as part of the trial design review.

Life revolves around p-values, trial power and performance goals

P-values, power and performance goals are the geeky pieces of information that statisticians care about.

Statisticians want to understand if the trial results (good or bad) are replicable in the real world.

They attempt to understand the probability of the certain benefits or risks to re-occur in real world once the medical products are commercially available.

Communicates study results numerically using tables and graphs

The Statistical Analysis Plan (SAP) specifies how the data will be analyzed.

Once the clinical data is analyzed, it presented beautifully in the form of tables and graphs. This is a key task as it forms the foundation of how the trial results will be communicated to the outside world.

Tables are graphs are utilized in clinical summary reports, annual updates, presentations and publications. Tables and graphs are also included on product Information For Use (IFU) documents and Patient Guides.

When the product is approved to be sold commercial, sales and marketing teams use government approved tables and graphs to promote the use of the drug or device.

Safety

This is a very interesting role for anyone who wants to be closest to the medical aspects of any clinical trial.

Safety touches most aspects of a clinical trial including the protocol, patient informed consent, patient safety outcomes in the final study report, Instructions for Use (IFU) document and more.

Understands regulatory requirements around patient safety

Regulatory agencies are most concerned about the safety of the clinical trial procedure and investigational device or drug.

The safety team has a thorough understanding of regulatory requirements pertaining to the safety of any clinical trial.

When patients are enrolled in a clinical trial, they may experience an adverse event. Clinical sites, sponsors and CROs are required to meet strict adverse event reporting requirements. This requirements can vary by country.

A safety team member has a clear understanding of regulatory requirements and helps ensure safety compliance.

Life revolves around adverse events management

A safety monitor champions all safety aspects of a clinical trial such as adverse events, clinical trial procedure risks, and device/ drug risks.

When a patient participates in a clinical trial, he or she may experience adverse events, also known as AEs. These AEs are reviewed by the safety team.

In some cases, there may be unexpected serious adverse events (SAEs) that may impact patient safety. When such events occur, the safety team evaluates and communicates the adverse event information with stakeholders such as clinical trial sites, patients, and regulatory agencies.

Manages Clinical Events and Data Monitoring Committees

When patients experience AEs, the clinical sites reports the AEs to the trial sponsor or CRO. The safety team reviews reported AEs and collects relevant medical records.

A subset of these AEs and the corresponding relevant medical records are sent to an physician committee, known as the Clinical Events Committee (CEC). The safety team manages the selection and operation of a CEC.

The basic premise of a clinical trial is that it’s a drug or medical device experiment on human beings. Participation in a clinical trial usually involves safety risks. Some safety risks are anticipated and others aren’t.

For unanticipated risks during the enrollment phase, a sponsor may recruit a data safety monitoring board (DMC). The DMC ensures there is no risk to patients in the trial.

Not all trials require DMC as duration of enrollment might be too small to detect a safety signal. Similar to CEC, the safety team leads the selection and management of a DMC.

Quality

Throughout my career, I’ve worked with clinical quality experts that either “police” every step in the clinical process or serve as a partner and resource to other clinical research functions.

In both cases, the ultimate goal of any clinical quality personnel is to keep you, your clinical trial and your organization out of trouble.

Ensures compliance in all aspects of a clinical trial

As we’ve discussed earlier, clinical research is a highly regulated industry. With regulations, comes compliance. Clinical research professionals need to comply with government regulations, Good Clinical Practice (GCP) and operating procedures.

You may ask, “What’s the purpose of all this compliance”?

Well, the simple answer is that outcome of a clinical trial sets a new medical standard or leads to an update of an existing medical standard.

Would you trust a drug or device that is brought to market based on a non-compliant clinical trial?

Probably not.

Happiness = No Audit Findings

Passing an audit is the ultimate test of any clinical research organization. This is especially true for audits by regulatory agencies.

Audit findings are painful not just for the quality team but for the entire clinical team. Significant audit findings also raise doubts about the robustness of a clinical trial.

Life revolves around Standard Operating Procedures (SOPs)

For instance, in the US, FDA regulations dictate how a clinical trial should be conducted. These regulations form the basis of standard operating procedures (SOPs).

A great quality associate helps a clinical research organization create and maintain a practical set of SOPs.

It is important to note that the burden of creating SOPs does not lie with clinical quality. Other clinical research functions are responsible for drafting and finalizing their own role-specific SOPs.

Understands Corrective and Preventive Action Plan (CAPA)

Since many aspects of clinical trials are managed by humans, the process is prone to errors. Errors can happen due to oversight, gap in a SOP, or mismanagement. A quality personnel initiates a CAPA when errors are discovered.

The goal of a CAPA is to document the error and take necessary steps prevent the error from happening in the future.

CAPAs are frowned up and are never a good thing for any organization. More CAPAs means there is greater risk, which in turn reduces the public’s confidence in the clinical trial outcomes, product or company.

Medical Writing

Clinical trial information is communicated with all stakeholders via clinical documents such as the protocol, clinical reports and manuscripts.

A medical writer leads the task for assimilating trial information and putting it together in a logical way.

Understands scientific content

A medical writer has an in-depth understanding of the therapeutic area and previous clinical and preclinical information on the drug or device.

Given the countless number of medical products and trials, it’s not unusual to learn trial or product specific information after joining the project.

Life revolves around writing protocols, reports or manuscripts

As a medical writer, you need to enjoy the process of writing. If you don’t enjoy writing, it will be painful to write several hundred pages of clinical trial documents on a regular basis.

A medical writer has a unique ability to communicate high-level clinical trial strategy vision in a document such a protocol or report.

Regulatory decisions are made based on these documents. Therefore it is extremely important for a writer to understand what regulators are looking for.

A medical writer is responsible for writing key clinical documents such as the protocol, clinical reports, safety charters, and more.

Punctuation, grammatical errors or typos can reduce the reviewers trust in the final document. Such errors make the company look sloppy in front of regulators, clinical sites or trial sponsor.

Additionally a medical writer needs to master writing software such as Microsoft Word. Inability to effectively use such software will cause issues with document formatting, resulting in delays and frustration.

Scientific

A scientist is responsible the clinical trial strategy. In some organizations, the role of the scientist may be combined with that of the medical writer or that of project management.

Brainchild behind overall clinical strategy

Prior to the start of any clinical trial, a lot of work is put into designing a cost-effective, safe and effective study. Depending on the trial design, there may be quite a bit of back-and-forth between the regulator and the sponsor or CRO.

A clinical trial can begin enrolling patients only after the regulatory alignment is obtained. The scientist champions the development of clinical documents and communication necessary to secure this regulatory alignment.

Life revolves around designing a trial that meets the primary endpoint

If you remember your life as a student (or maybe you’re still a student), your final grade on the test depends on how well you do on the finals.

Along the same lines, the success of any clinical trial is determined on whether or not it meets a pre-specified primary endpoint.

The trial endpoints are clearly stated in the protocol. Once the primary endpoint is met, the medical product will most likely be approved for commercialization.

Happiness = Abundance of high quality clinical trial data

The success of a clinical trial is hinged on high quality clinical trial data. But what does “high quality” mean?

High quality data is error free, accurate, and complete. Missing or incomplete data due to missed visits or sloppy data entry can cause headaches for many clinical stakeholders, primarily the clinical scientist.

Also there can be a tendency to collect more data than needed for “just in case” scenarios such as unanticipated requests from regulators or potential for interesting publications in future years.

Systems and Solutions

Not too long ago, clinical trial data was collected on paper case report forms. Then it became incredibly hard to manage data queries, keep track of complete forms and manual entry of data from paper into an electronic database.

With the help of technology, electronic data capture (EDC) solutions were developed. Now site staff can directly enter data in the case report forms.

The Systems and Solutions team is responsible for managing clinical technology solutions such as the EDC. They are also responsible for onboarding new technology solutions and retiring old solutions that no longer add value to the organization.

Technology backbone for clinical trials

More than ever before, technology is becoming an integral part of clinical research. The system and solutions group is the technology backbone for clinical trials.

Want to incorporate wearable technology in a clinical study?

Or build an iPhone app to organize study team contact?

Clinical systems and solutions group is your go-to team.

Depending on the size of the company, this role may be separate function within clinical research or part of the information technology (IT) organization.

The TMF allows you to store study and site level documents in electronic format. A CTMS is useful for managing study contact information. EDC allows sponsors to design electronic case report forms and allows sites to remotely enter data into the system. The IxRS serves to register patients to a specific treatment.

In addition, there may be other systems for safety management and reporting, protocol deviation and monitoring visit management.

Understands regulatory requirements for technology solutions

Regulators are interested in ensuring clinical trial technology is compliant with the law.

Systems and solutions team needs to have an in-depth understanding of regulatory requirements pertaining to technology solutions.

Regulators such as the FDA frequently publish guidance documents related to a specific technology product. Guidance documents can be easily accessed via the FDA website and can serve as a great resource for anyone wanting to dig deep in a specific clinical technology area.

Clinical trial costs can run into millions of dollars. By controlling project timelines and resources, a senior manager can control expenses.

In addition, it is crucial to ensure the trial is conducted in compliance with regulations and internal procedures.

Finally if the study is not scientifically robust, the clinical trial may not get regulatory approval.

It is not possible for one individual to be competent in all these areas. For this reason, a senior management team is needed to collaboratively achieve the strategic goals.

Interested in Key Performance Indicators (KPIs)

Do you have a retirement account?

Or go to the doctor for an annual check-up?

If so, you’re probably paying attention to the performance of your retirement fund or your health over a period of time.

Along the same lines, senior managers are interested in a set of KPIs that track the performance of a clinical trial against a standard or threshold.

For example, regulators want to ensure patients sign the correct version of the informed consent form (ICF). Signing an incorrect ICF version is a major compliance issue. Thus ICF deviation rate can be a KPI.

Since senior managers are not involved in the day-to-day operations of the trial, they assess the health of a project by reviewing KPI metrics. If KPI metrics trend towards non-compliance, senior managers will take steps to address the issues.

Other Adjacent Functions

A clinical department frequently collaborates and seeks help from other teams. The section below covers the key teams that interact and support clinical teams on a regular basis.

Since the focus of this post is clinical research, the role of these adjacent functions has been described keeping in mind the clinical context.

Regulatory Affairs

Regulatory Affairs (RA) is responsible for the regulatory strategy and submissions. For a clinical trial, a RA team member is generally the primary contact person for the regulator such as the US FDA, Japan PMDA, China FDA.

Deep understanding of regulatory process and requirements

Ready to start a clinical trial? Or address clinical trial deficiencies with the regulator?

You’ll want to start with your regulatory affairs team. Clinical trials are conducted in compliance with regulations. RA can educate you on the clinical documents needed to meet regulatory requirements in a given geography.

A regulatory affairs expert has an in-depth understanding of the regulatory process and requirements.

Adept at reviewing and editing clinical submission documents

Once the clinical team has created the necessary documents such as the protocol, statistical analysis plan or the clinical summary report, a regulatory affairs associate performs a detailed review of the documents.

In addition, regulators have specific formatting requirements such as cover letters and forms that need to be completed with every submission.

Focus is on regulatory agency alignment on all aspects of clinical research

There is specific way of communicating clinical trial information with regulators. This communication style is very different from the day-to-day communication amongst clinical research team members. A seasoned regulatory affairs expert understands this nuance and is able to communicate effectively with regulators.

Happiness = product/indication approvals

A success of a regulatory affairs team is measured by product and indication approvals. It’s no easy task to get a product to market, especially for new therapies.

Health Economics and Outcomes Research (HEOR)

Getting medical products or indications approvals is always great news.

But here’s the deal.

You need someone to pay for the approved drug or device. If payors such as insurance companies or Medicare are not willing to provide reimbursement, it can significantly hurt a company’s bottom line.

This is where HEOR comes into play. A HEOR team helps create a body of evidence that the new drug or device has health benefits such as improved quality of life.

Deep understanding of payor process and requirements

A HEOR expert can help you develop a robust protocol and case report, so you can proactively collect the clinical data needed for reimbursement.

HEOR has an in-depth understanding of country specific requirements. Their work leads to maximum medical product reimbursement for the company.

Understands medical product impact on Quality of Life (QoL)

Let’s say your friend experienced a heart attack and got a stent. Now 10 years have passed. Your friend has not experienced any new heart problems. He feels great, goes for a morning run and is able to spend quality time with his family.

How would you rate his quality of life? Excellent, right?

HEOR pays much attention to a patient’s quality of life. In addition to being safe and effective, medical products need to have a positive impact on a patient’s quality of life.

There are many tools available to measure such quality of life. Clinical trials include quality of life questionnaires for patients to complete. This data is then analysed and utilized to secure reimbursement approvals.

Happiness = Maximum product reimbursement

One of the primary roles of the HEOR team is to ensure the medical product receives maximum reimbursement possible.

Reimbursement can vary significantly based on country laws or availability of new health data. For example, Japan offers higher reimbursement for newer medical products but then decreases reimbursement in future years.

Clinical Research Organizations (CROs) and Consultants

Some sponsors hire full time staff to manage their trials. Some outsource all clinical research tasks to CROs and consultants. While others may use a combination of internal and external resources.

Supports sponsor by filling in resource and talent gaps

It is expensive to build a full clinical team, especially for an organization with limited financial resources. CROs can help fill the talent gap for each of the clinical research roles discussed in this post.

Work is billable

A major chunk of clinical trial costs is full-time salaries paid for each of clinical roles explained in this post.

CROs and consultants charge by the hour or by deliverable. The “pay by hour” or “pay by deliverable” model gives sponsors greater flexibility and control on expenses.

People that work for a CRO may be full time employees or contractors. At any given time, a CRO or a consultant may be working on multiple projects for different sponsors.

Can help reduce fixed overhead expenses

For smaller organizations, steady cash flow can be an issue. Therefore having a full clinical team means paying for employee salaries, office space, health insurance and other benefits. This can be cost prohibitive.

Legal

A clinical research cannot be conducted without legal support. You’d open yourself to all sorts of risks if you didn’t have an lawyer on your team.

Complete understanding of legal landscape

A lawyer with clinical research experience has an understanding of intellectual property law (patents, trademarks), legal entities i.e. how the hospitals or supplier are structured from legal standpoint, supplier contracts, subject injury and liabilities, and more.

Happiness = 100% compliance including no lawsuits

A lawyer will be extremely happy if a company is successfully able to conduct a clinical trial in a legally compliant manner.

For instance, there is great risk to patients participating in clinical trials. If the legal language on the informed consent form or clinical trial contract between the site and sponsor is inadequate or unclear, it can lead to lawsuits.

Lawsuits impact the company’s finances, brand and reputation. A legal team ensures the company does not end up in legal troubles with any of clinical trial stakeholders.

Conclusion:

By now you have an in-depth understanding of all clinical research functions and teams that support clinical trials.

Clinical research and clinical trial management involve cross-functional teams. The chart below summarizes the roles of different clinical research team members.

Which clinical research function interests you the most? Leave your response in the comments section below.

]]>http://clinicaltrialpodcast.com/clinical-research/feed/725 Soft Skills To Boost Your Clinical Research Careerhttp://clinicaltrialpodcast.com/25-soft-skills-to-boost-your-clinical-research-career/
http://clinicaltrialpodcast.com/25-soft-skills-to-boost-your-clinical-research-career/#respondTue, 21 Feb 2017 05:48:09 +0000http://clinicaltrialpodcast.com/?p=303As clinical research professionals, we often hear about GCP, HIPAA, compliance, monitoring, Code of Federal Regulations (CFR), so on and so forth. When trying to secure that next promotion, we often focus on our clinical research skills: the ability to enroll a trial fast, locking that trial database on schedule...

As clinical research professionals, we often hear about GCP, HIPAA, compliance, monitoring, Code of Federal Regulations (CFR), so on and so forth.

When trying to secure that next promotion, we often focus on our clinical research skills: the ability to enroll a trial fast, locking that trial database on schedule or passing the FDA audit.

Rarely we take a step back and think about soft skills. Today soft skills are more important than ever. It would be too dangerous to ignore them.

In this post, I’ll share my top 25 favorite soft skills in a clinical research context. You can leverage these soft skills in all areas of your life as well.

So let’s get started:

1. Adaptability to changing requirements

Globalization and harmonization continue to change the clinical research landscape. For example, in the medical device world, the most talked about changes are European Medical Device Directive (MDD). There is a lot of buzz on this topic (and complaining too).

Last year I attended a one day roadshow hosted by BSI Group. The presenter asked people to raise their hands if they had read the draft MDD. Less than 5 people in a room of 100+ attendees raised their hands. This goes to show how underprepared the audience was. Very few people had invested the time to understand the proposed changes to the MDD. Yet most of us we anxious about how the change was going to impact our work.

The question you must ask yourself “how will I adapt to these changes?” Change is not limited to government regulations. You’ll experience unanticipated changes in your department, your role, or on your project. Take some quiet time to understand change and then adapt.

Change is always hard because it forces us to break our old habits and form new habits.

2. Authenticity and consistent behavior

Being authentic and consistent is hard work.

For example, if you are CRA responsible for on-site monitoring, you probably expect the research coordinator to respond to your emails, answer open queries and complete data entry in a timely manner. When you visit the site, you want the research coordinator to welcome you with a smile.

However as a CRA, you are equally responsible for authentic and consistent behavior. As CRA you need to show up on time for the monitoring visit, send out monitoring follow-up letters within a few days of your visit (not weeks or months), and answer research coordinator questions with great accuracy and a smile.

Many of us fail to see the other side of the equation, especially when we feel we are in charge of the situation. Being authentic and consistent is hardest when no one is watching us.

3. Coach-ability and the desire to coach others

When I was a CRA, I remember my project manager required our team to cross train each other. At that time, I thought cross-training was a waste of time. Obviously the project manager wanted team members to be cross-trained, should someone decide to quit their job.

But aside from this obvious reason for coaching others, there are many other benefits. If you take the time to teach someone how to use the excel spreadsheet you’ve created or explain the clinical jargon in the protocol, they’ll always remember you for helping them succeed. This in turn creates a lot of goodwill and karma.

4. Collaborative mindset

You may have heard a coworker say, “He is very territorial.” Rather than being afraid of others eating our share of the pie, we must develop an abundance mindset. The more willing you are to collaborate with our fellow colleagues, the more respect you’ll earn. This in turn will create opportunities for you and others.

Clinical trials requires cross-functional expertise to succeed. Every person involved in the clinical trial has a role to play. Learn to collaborate with an open and curious mind.

5. Conscientiousness in keeping promises

When was the last time you or someone you know, made a promise and couldn’t keep it? I bet you can think of at least one situation in the recent past.

As clinical research professionals, we’re constantly bombarded with requests from sites, sponsors or our management. We generally agree to everything that gets sent our way. It’s hard to say “No”, especially to someone who we wish to please.

But what’s worse is that you get overwhelmed and can’t keep your promises. This leaves a bad impression with the other person.

Before you make your next promise, think about everything you have going on personally and professionally. You can always ask for time to think about the request before making a commitment.

6. Customer service passion

Whether you work at a clinical site, sponsor, clinical research organization (CRO) or the government, providing exceptional customer service to internal and external stakeholders can go a long way in building strong and positive working relationships.

Let’s use CRO-sponsor relationship as an example. The CRO works for the sponsor. It’s expected that the CRO provides excellent customer service to the sponsor. How about the sponsor providing excellent customer service to the CRO as well?

Sponsors can help CROs be successful at their job by documenting clear expectations, addressing areas of ambiguity and being transparent.

When I’m frustrated with customer service, I say to myself, “They are trying to do their very best.” This immediately puts me in a mindset of acceptance and empathy.

7. Eagerness to learn from criticism

Whether you work at an organization or run your own clinical research business, you can’t escape from criticism. There will always be someone who is going to be unhappy with you. Rather than reacting to the criticism, you must welcome it with both hands and learn from it.

Sites criticize sponsors for creating a complex clinical protocols, sponsors criticize regulatory agencies for not accepting their clinical strategy, and a CRO criticizes sponsors for being too demanding at all times.

Spend the time to understand the root cause for such criticism. It might be worth having discussions in a team environment to dissect the cause and how you can learn and improve in the future.

8. Enthusiasm for the work

Yawning is contagious. So is enthusiasm. If you’re enthusiastic for the work, you’ll get others excited too. Your output at work will be much better too.

Bored to read that Standard Operating Procedure? Or don’t want to write that clinical study report? Well, the good news is that everyone experiences dull moments. Enthusiasm is what keeps us going.

9. Ethics even when not under scrutiny

Clinical research and ethics are two sides of the same coin. For example, you don’t want to to take shortcuts by not following procedures. The impact of your decision to take shortcuts can result in a serious audit finding years later.

10. Managing difficult conversations

Difficult conversations can be emotionally exhausting. I remember several difficult conversations I’ve had over the years, particularly with employees who were a misfit for the organization.

If you’re a people manager, you need to learn the art of having difficult conversations with your team. If there are performance concerns, don’t wait till that next annual review. Be proactive and provide ongoing feedback – good and bad. People appreciate knowing where they stand.

11. Motivated to take on new challenges

Sooner or later you’ll asked to take on new challenges,asked to do things that make you uncomfortable. Some challenges are more direct and others are subtle. For example, if you are a clinical research assistant, you may be notice that the team needs help with some higher level work to meet a timeline. Put yourself out there and make it known that you are willing to take on new challenges.

Remember that there may not be any immediate financial benefits to you. However it is certain that you’ll grow personally and professionally as a result of taking on the new challenge.

12. Self awareness

If there is one soft skill you must master on this list, it’s self awareness. As clinical research professionals, we’re constantly interacting with various stakeholders. Before reacting to any situation, you want to be in full control of yourself by being self-aware.

For example, if you are choosing to take a tough stance on an issue, be sure to understand the “why” behind your decision. Don’t be tough for the sake of being tough. Put yourself in the other person’s shoes before you call the shots.

13. Sense of humor

A few years ago, I remember a conversation between a Clinical Vice President (VP) and a well-respected clinician. The clinician wanted to design a very large sample size study. But there was no scientific or statistical reasoning behind the clinician’s proposal. The VP was quick to comment, “I’ve never heard you be so unscientific in all the years we’ve worked together” The VP’s comment broke everyone into laughter, making it easier to have the much harder conversation of reducing the sample size.

Clinical research is a regulated industry. We’re always talking about compliance, patient safety and good clinical practice. A sense of humor can put you and your colleagues at ease and not take everything so seriously.

14. Diligence and attention to detail

Paying attention to details is exceptionally important. Some people, intentionally or unintentionally, just don’t pay attention to details.

For example, if you are planning an investigator meeting, you need to understand pay attention to meeting logistics and content. Why? Because you’re inviting physicians and research coordinators to spend anywhere between 2-16 hours on your project. If you expect them to the attentive during your presentations, the meeting flow needs to be top notch with every single detail mapped out.

Another area where attention to details is necessary is medical writing. Writing clinical reports is not an easy task. Combined that with paying attention to document formatting and grammar can be daunting. If you are not good with formatting documents, learn to master the skill or outsource the work.

15. Facilitation of discussion

We’ve all been through painful meetings. People give boring “updates” on a project or simply digress on the least important topic on the agenda.

Facilitating an effective discussion by asking the right questions will help you long way. When holding meetings, you need think about the purpose of your meeting and focus on achieving that purpose. If the purpose is to provide updates, more often than not, it can be achieved through a well crafted update summary. People can read the summary at a time that works best for them.

16. Listening skills

A few years back, my manager at the time gave a four bullet feedback. One of the bullets read, “Talk Less, Listen More.” As humans, we love to talk. But if you can master the art of listening, you’ll start to understand what really matters to the person you are communicating with. Once you know what matters, you can tailor your response to address that person’s question or concern.

We’ve all been on a few teleconference calls where people are talking over each other. Let’s not do that.

17. Managing up

When you land with your first job, no one tells us that you need to learn how to “manage up.” You may be putting in a ton of hours at work. Yet your manager may be disappointed with your performance.

Seldom do managers want to give their employees a hard time. Infact it’s in the best interest of the manager to keep an employee happy at work. Learning to manage up, gives you the ability to get in sync with your manager.

For example, a site investigator may expect the research coordinator to lead a dozen clinical studies. The coordinator single handedly can’t possibly manage such a heavy workload without burning out. But the coordinator can track how long it is taking her to perform her tasks. She can share this data with the investigator to discuss potential options to make her workload more manageable.

When you are managing up, don’t be defensive. Instead explain the issue you are facing in calm and objective manner, backed by real data.

18. Planning for projects

Planning for projects shouldn’t be left to the project manager. Although it’s nice if the project manager did all the project planning for us. As a clinical researcher, you’re likely have your own projects or deliverables.

For example, a clinical quality manager may be responsible for developing or updating standard operating procedures. She would need to allocate focused time to update procedures, schedule time with other team members to get their input t on the procedure changes, read FDA guidance documents to understand the regulatory landscape and more.

Planning for projects can be boring because you’re tempted to spend that extra time on doing the work itself and planning seems like a huge waste of time. However when you actually sit down and write your plan on paper, it helps bring clarity to your mind and work.

19. Technology savvy

I love technology. It helps us do our work faster and better. I won’t argue with you if you told me technology also leads to issues that can take a long time to fix. But overall, we are net positive with technology.

As an clinical research industry, we should leverage technology to make research more interesting and engaging. Being tech savvy doesn’t end once you learn how to use Microsoft Word, Excel, PowerPoint or Electronic Data Capture (EDC) systems.

For example, sponsors can use email software such as Marketo to send out well-designed clinical trial newsletters to research sites rather sending an email with a PDF attachment that very few people bother to open.

Other ideas include the use of electronic informed consent solutions (eICF), transfer imaging data online rather than via courier services or using social media to recruit patients.

20. Conflict resolution instincts

We’re prone to conflicts because each one of us has a unique worldview. This leads to disagreements. Developing conflict resolution instincts can take years of practice. One strategy I’ve found particularly useful is putting myself in the other person’s shoes.

For example, let’s assume you and your colleague are disagreeing on the clinical protocol design. It would be wise for you to take the time to understand your colleagues concerns. Discuss or think through the concerns one-by-one and be creative about mutually resolving disagreements.

Ultimately a few concerns will need to be elevated to senior leadership. But atleast you and your colleague would have vetted out most issues before escalating to the next level.

21. Creativity in the face of challenges

It is quite common to face challenges when conducting research.

It’s taking months to negotiate a clinical trial contract, the CRO is not meeting sponsor expectations, patient recruitment is significantly slow and an audit led to major findings are some common challenges.

Rather than reacting to these challenges, it’s important to take a step back and brainstorm all potential solutions to the challenge at hand. In order to come up with creative solutions, you need to have an open and curious mind.

22. Dealing with difficult people

There are many ways to deal with difficult people. You approach will vary depending on whether the difficult person you are dealing with is your subordinate, supervisor or colleague.

My only suggestion when it comes to dealing with difficult individuals is that you conserve your finite amount of energy. If you drain your energy in trying to correct other people, you’ll distract yourself from fulfilling your own dreams and doing work that actually matters.

23. Diplomacy in difficult situations

The author Maya Angelou once said, “I’ve learned that people will forget what you said, people will forget what you did, but people will never forget how you made them feel”.

When you find yourself in difficult situations, don’t say things that will hurt the other person or make the feel bad about themselves.

I also find myself using silence as a way to gather my thoughts before speaking my mind in difficult situations.

24. Storytelling

You may feel that storytelling does not apply to clinical research. But actually take a minute now to think about any talk or presentation you thoroughly enjoyed. I bet the speaker was harnessing the power of storytelling.

Humans love stories. Therefore the next time you are invited to present at an investigator meeting or a site initiation visit, practice storytelling. Don’t read the slides verbatim because no one will remember you or what you said.

25. Empathy for customers, co-workers and vendors

Being able to understand the feelings of our customers, coworkers and vendors makes us more approachable. People will want to connect with you if you care about them. Showing empathy is not a sign of weakness but rather of strength and maturity.

For example, assume you are a CRA out at a site for a monitoring visit. If the research coordinator is stressed about missing patient records, you can express empathy by acknowledging the coordinator’s efforts in trying to find the missing records. The missing records won’t magically appear. However the coordinator will recognize the fact that you are able to understand her plight.

Summary:

We’ve covered 25 foundational soft skills that will serve well in your clinical research career. In order to put these skills to practice, pick just one soft skill and practice it for 30 days. Then see what magic is does for you. At the end of 30-days, spend 30 minutes reflecting what worked well and what didn’t. Then move onto the next skill of your choice. Within a year, you would have mastered 12 soft skills.That’s lot!

Let me know if which soft skill you’re planning to put into practice next and why? I’d love to hear your thoughts, ideas and suggestions in the comments sections below.

]]>http://clinicaltrialpodcast.com/25-soft-skills-to-boost-your-clinical-research-career/feed/0Ultimate Guide To Clinical Trial Costshttp://clinicaltrialpodcast.com/ultimate-guide-to-clinical-trial-costs/
http://clinicaltrialpodcast.com/ultimate-guide-to-clinical-trial-costs/#commentsSun, 22 Jan 2017 03:57:32 +0000http://clinicaltrialpodcast.com/?p=284Have you been tasked to develop clinical trial budget? Well you’re in luck because I’m going to share everything you need to know about clinical trial costs. Clinical trial budgets are often put together in haste. The focus is on getting the product to market as quickly as possibly. Or...

Have you been tasked to develop clinical trial budget? Well you’re in luck because I’m going to share everything you need to know about clinical trial costs.

Clinical trial budgets are often put together in haste. The focus is on getting the product to market as quickly as possibly. Or revenues and profits.

Developing a clinical trial budget can be a confusing exercise for sponsors and CROs. There are too many cost variables to account for.

This post covers the key cost drivers for medical device clinical trials. If you are a researcher or financial analyst working in clinical research space or simply curious about clinical trial costs, this post will serve you well.

So let’s get started.

1. Patient Grant

Patient grant costs are broken down into screening, baseline and follow-up visits and medical imaging costs.

a. Screen failures

Clinical trial protocols have inclusion and exclusion criteria to qualify patients. Strict inclusions and exclusion criteria reduce the available patient pool for trial enrollment. Clinical sites spend physician and site coordinator time to screen for potential patients.

During the budgeting process, map out the complete patient screening workflow. Speak with a few clinical sites to understand how many patients they would have to see in order to find one qualified patient. For example, a site may need to screen four patients to find one qualified patient. Understand how many hours the site is spending on screening activities and reimburse accordingly. Therefore it’s not unusual to reimburse sites anywhere between $50 to $250+ per screen failure.

b. Baseline/index procedure and follow-up visits

Depending on the clinical trial design, data is collected at baseline or index procedures and follow-up visits. The site coordinator is generally responsible for entering the data in the case report form. Sites are reimbursed for the time spent to collect clinical trial data.

Based on number and type data fields you are collecting, you’ll want to estimate the site coordinator time needed to collect and input trial data. Then multiply the estimated coordinator time by the hourly bill rate to obtain the fair market value for each patient visit.

In some cases, sponsors may choose to reimburse patients. Reimbursement for patients can include paying for their participation, reimbursement for travel, meals or overnight hotel stays.

c. Non-standard of care tests

Medical device trials may require non-standard of care tests such as medical imaging scans. Insurance companies or medical care agencies generally do not reimburse non-standard of care costs. Therefore you should include them in your clinical trial budget.

d. Procedure costs

Medical payor such as Medicare or private insurance may reimburse clinical trial procedure costs. If procedure reimbursement is available, you don’t need to budget for the procedure cost. In case a brand new procedure where no reimbursement available, budget for the procedure costs.

2. Site costs

a. Start-up fees

Clinical sites spend significant time to initiate a new clinical trial. Sites are responsible for site specific informed consent development, Ethics Committee (EC)/ Investigational Review Board (IRB) submissions, staff training including participation in investigator/ site coordinator meetings and site initiation visits and execute a clinical trial contract. It is typical for sponsor to pay anywhere between $2000 – $5000+ in site start-up fees.

b. EC/IRB fees

EC/IRB fees are in addition to site start-up fees. These fees cover the time spent by EC/IRB to plan and conduct review of the clinical trial protocol and other associated materials. Many EC/IRBs update and publish their rates annually.

c. Close-out fees

Close-out fees include time spent by site staff to reconcile clinical trial data, finances and regulatory documents during study closure. Not all sites require this payment but has started to become a more common practice in recent years.

d. Storage Fees

Government regulations require that clinical trial data be stored after study close-out. The duration for storage can range from 2-years to permanent storage. Thus it’s not uncommon for sites to have boxes of regulatory paperwork that need to be stored once a clinical trial ends. The storage fees vary by country and site.

Some sponsors make arrangements for site to send trial documents to an offsite storage location. Due to country specific regulations, a site might be unable to move documents outside their country.

e. Administrative overhead

Clinical sites may require as much as 30% administrative overhead in addition to per patient grant amount. This cost covers management and legal resources needed to provide clinical research oversight and legal review of clinical contracts respectively.

f. Site Management Organization (SMO)

In certain countries such as Japan, data entry and collection tasks are outsourced to SMOs. For post approval studies, sites do not research coordinator support. Thus sponsors are expected to hire SMOs to support the site or pay the sites to hire their preferred SMOs.

3. Non-patient costs

a. Clinical Evaluation Committee (CEC)

Adverse event and endpoint data is adjudicated by a non-biased, independent CEC. CEC is generally composed 3 or more physicians. CEC members review adverse events and trial endpoints in a team setting or independently.

A sponsor can hire physicians to serve as the CEC and reimburse them at fair market value rates. It is more cost effective for sponsor to contract with physicians directly. But the sponsor has to assign its own resources to manage the CEC.

The other option is for the sponsor to outsource management and conduct of CEC activities. However this option is more expensive because you are hiring professionals to manage the CEC.

CEC is a very important component of medical device clinical trial. Adjudicated adverse event data is highly regarded by regulatory agencies and the physician community. In many cases, it is a requirement to have adjudicated adverse event data in order to get the product on market.

b. Data Safety Monitoring Board (DSMB)

DSMB is sometimes known as the the Data Monitoring Committee (DMC). According to IMARC research, the purpose of the DMC is to advise the sponsor on continuing safety of the trial subjects and those yet to be recruited and provide continuing validity and scientific merit of the study.

For budgeting purposes, it is important to know that DSMB is required during trial enrollment phase. In some cases DSMB meetings occur till all patients have reached their primary endpoint. The decision of whether or not to conduct DSMB meetings after the primary endpoint is reached, is up to the sponsor.

c. Physician consulting

Physicians are consulted during all phases of a clinical trial. Physician guidance is needed to develop clinical trial strategy, enrollment plan, final data analysis and publication plans.

Physician consulting costs can be anywhere between $150 – $600+ per hour. The billable rate varies based on physician’s medical expertise and geographical location. If a clinical trial is interesting to the physician, he or she may be willing to provide consulting services at little or no cost.

d. Independent corelab analysis

Many medical device trials collect imaging data such as angiograms, CT scans and X-Rays. Since this data comes from multiple sites, variability is expected. An independent corelab standardizes the collection and analysis of imaging data.

Corelab costs can add up quickly. Costs depend upon the number of images analyzed per patient, the time it takes for the corelab to analyze the data, and the duration of the trial.

Corelabs usually hire analysts to collect and calibrate data from different sites. The final analysis is usually done by a physician. Given the complexity of imaging data collection and analysis combined with the importance of corelab data to regulatory agencies, it is important that adequate and accurate budget is allocated for independent corelab analysis.

e. Medical device cost

Once you are ready to enroll patients in the clinical trial, you’ll need to ship medical devices to the sites. Most sites will expect to receive these devices for free. The only exception is when conducting post approval trials for commercially available devices.

Medical device manufacturers conduct trials for indication expansion. For example, a stent company may conduct a trial to get their heart stent approved for use in a different anatomy. For such expansion trials, sponsors may need to provide commercially available devices to sites at no cost.

Whether or not you want to provide devices at no cost is a business decision. When investigational medical devices are provided at no cost, sites enroll faster and have a much stronger, collaborative relationship with the sponsor.

4. Labor Costs

In order to conduct a clinical trial, you need to hire people that have expertise in clinical research and clinical trial management. Depending on the size of the trial and the number of trials conducted, resource allocations vary. Therefore amount of labor needed to run a study also varies.

a. Clinical Research Assistants or Associates (CRAs)

CRAs are primarily responsible for monitoring clinical trial data that is collected during the course of the study. They visit clinical research sites to ensure data is collected in a compliant manner.

A project manager’s responsibilities can vary from one organization to another. Project managers are like “general contractors.” A project manager is responsible for managing the clinical trial budget, resources and timelines. The core function of a project manager is to resolve or escalate issues that come up during the course of a clinical study.

c. Data Manager

A data manager’s job is to address data discrepancy issues by generating queries to sites. Data managers may also be responsible for implementing electronic data capture system or paper case report forms needed to collect trial data.

d. Scientist

The scientist is primarily responsible for developing the clinical strategy for a trial. Individuals with Ph.D. or M.D. degrees are usually the right fit for this role. In some organizations, the project manager also play the role of the scientist.

e. Biostatistician

A biostatistician is responsible for developing a statistical analysis plan (SAP). The SAP documents on the data will be analyzed during the course of the study. A statistician or statistical programmer is also responsible for programming data tables that are incorporated in the final clinical study reports.

f. Quality

Clinical research is a regulated industry. Quality plays an important role in ensuring sponsors, CROs, and clinical sites are conducting the trial in a compliant manner. Thus a quality associate or manager helps an organization create and implement standard operating procedures (SOPs).

Salaries for these roles can vary by geography and experience. The above list is not comprehensive. However it should give you an idea of the core resources needed to conduct a medical device clinical trial.

5. Site Management

a. Pre-study visits

Prior to inviting any site to participate in a clinical trial, you want to conduct pre-study visit, also know as the site assessment visit. This visit becomes even more important if you don’t have any prior experience working with the site in a clinical or commercial setting.

Although sites don’t charge for this visit, the sponsor will need to pay for travel and CRA labor costs.

b. Site Initiation Visits (SIV)

Once the site has received Institutional Review Board (IRB) or Ethics Committee (EC) approval and the trial contract has been signed, it’s time to activate the site for patient enrollment.

A SIV is conducted when you are ready to activate the site. SIV involves training the site on the clinical protocol and any other study-specific requirements.

Similar to the a pre-study visit, the sponsor will need to pay for travel and CRA labor costs.

c. Monitoring

Once patients are enrolled in the study, it is critical to collect data in a compliance with regulations and the clinical study protocol. This is when monitoring comes into play.

A CRA, sometimes known as the site monitor, visits clinical sites at regular intervals to ensure compliance.

In recent years, due to push for reduction in clinical trial costs, several sponsors have started to monitor remotely rather than conducting an in-person monitoring trip.

d. Close-out

Once all patients at a site have completed their follow-up visits, it’s time to conduct a close-out visit. Any open items related to study conduct are addressed during the close-out visit.

6. Miscellaneous

a. Investigator Meetings

Investigator Meetings serve to kick-off a new clinical trial. Site investigators and research coordinators are invited to participate in a 1-2 day meeting. These meetings serve to educate site personnel on the clinical trial protocol and any other trial specific requirements.

These meetings can be quite expensive and the sponsor pays for attendee airfare, hotel and meals.

b. Travel

Plan and budget for ad hoc travel. Clinical research is highly regulated. You’ll need to visit a site to address a compliance issue or help them prepare for an audit. In other cases, you want to visit a site to motivate them to enroll patients. Whatever the case may be, it’s always good to have a bit of money set aside for travel.

c. Document Translations

Document translations cost increase significantly depending on the countries in which the clinical trial is conducted. Sites where English is not the primary language, you may receive request for translation of key documents such as the protocol and site specific informed consent in the local language.

Also if the adverse event source documents from non-English speaking sites are in their native language, additional costs will incur to translate documents into English for event adjudication purposes.

e. Regulatory filing fees

Don’t overlook regulatory filing fees. These fees can run into thousands of dollars. Depending on the class of medical device, different applications are filed with regulatory agencies, competent authorities and notified bodies.

c. Trial enrollment delays

Enrolling in trials is tricky business. It takes longer to complete enrollment and initial projections are overly optimistic. Therefore account for these delays when you develop your clinical trial budget.

Conclusion:

We’ve covered a lot of ground in this Ultimate Guide to Clinical Trial Costs. To summarize, you should now have a solid understanding of these factors that impact clinical trial costs:

]]>http://clinicaltrialpodcast.com/ultimate-guide-to-clinical-trial-costs/feed/510 Smart Strategies to Getting Response from Clinical Site Coordinatorshttp://clinicaltrialpodcast.com/10-smart-strategies-getting-response-clinical-site-coordinators/
http://clinicaltrialpodcast.com/10-smart-strategies-getting-response-clinical-site-coordinators/#commentsSat, 12 Nov 2016 05:42:34 +0000http://clinicaltrialpodcast.com/?p=229Getting response from clinical site coordinators can be a constant battle of repeated follow-ups. There are many reasons why site coordinators don’t respond or are slow to respond. Today site coordinators receive continuous stream of communication from multiple sponsors and CROs. This communication comes through emails, phone calls, in-person visits...

Getting response from clinical site coordinators can be a constant battle of repeated follow-ups.

There are many reasons why site coordinators don’t respond or are slow to respond. Today site coordinators receive continuous stream of communication from multiple sponsors and CROs. This communication comes through emails, phone calls, in-person visits and other internet-enabled mediums. Every clinical trial requires site coordinators to get trained on trial-specific systems.

Site coordinators are responsible for seeing patients, negotiating contracts, submitting IRB/EC packed and collecting clinical trial data. This gets overwhelming, especially if the site is understaffed. In other situations, the clinical research responsibilities are divided across various departments. For example, contracts are managed by the legal team. The division of work can reduce the burden on the site coordinator. But if the legal department is slow to respond or does not understand clinical research space, site coordinator ends up having to deal with additional communication.

In this post, I’ll share smart strategies to getting response from clinical site coordinators.

Combine your requests

When possible, batch your requests to the site coordinator. By batching your requests, you are allowing the coordinator to be more productive. A continuous stream of ad hoc requests and communication is distracting. Unless there is a reason to separate your requests, opt for combined, comprehensive communication.

Offer to work directly with other departments such as legal or IT on specific tasks

At many large and some smaller clinical sites, different departments handle different tasks. This makes coordinators job stressful and busy. If you have the ability to provide additional support, lend an extra hand to the coordinator. If the site coordinator accepts your help, be sure to keep her in the loop on the progress and challenges.

Provide clinical research tools that actually help the site coordinator

Often clinical trial sponsors and CROs create tools that are not effective in helping the site coordinator do her job. Challenge yourself to think outside the box. Leverage technology to address site coordinator pain points. Use a survey tool such as SurveyGizmo to gather feedback from your sites on what will help them them most.

Communicate regularly and do not surprise site coordinators with tight timelines

Is your project team planning for a database lock 3, 6 or 9 months from now? If so, start communicating early with the site coordinators. Inform site coordinators about potential due dates for query resolution, source data verification, data entry etc. in advance. It is the responsibility of the clinical research associates and project management team to work closely communicate strategize on timely site communication.

Commend site coordinators in front of his or her manager or site investigator

Publicly appreciating site coordinators, especially in front of her manager or site investigators can go a long way. Kind words are always welcome and never enough. Your site coordinator will see you as a trusted partner.

Be soft spoken, calm and professional at all times

It’s too easy to let your emotions take control, especially when you are stressed. There will be times when the site coordinator will be unresponsive or slow to respond. It is important that you stay calm and professional at all times. There is no need to show your frustration or anger, as it will almost always work against you. If the site coordinator is not willing to cooperate or collaborate, brainstorm alternatives with her or your internal team.

Recognize gaps in the site coordinators skills, and use it as an educational opportunity

Not everyone is a born clinical researcher. Many clinical research skills are learnt through experience and training. If you find that your site coordinator is struggling on a given task, think about ways you can offer to help her. If you know of resources that can help her, ask if she would like for you to share them. Only after she agrees, share what you have to offer. Providing unsolicited advice can make you look arrogant.

Determine the preferred communication frequency, method of communication and time of day

Understand your site coordinators communication preferences. Does she prefer to be reached via phone, email, pager or text message? Does the frequency of communication matter? In other words, if you are emailing or calling her more than 5 times a day, is that going to be annoying? The time of the day you reach out to site coordinator may also be important as many coordinators are also nurses who meet with patients at certain times of the day. Feel free to discuss communication preferences every time you start working with a new coordinator.

Be specific on when you need a response

I still receive emails requesting for something with no due date for the response and then the individual is upset because I did not respond instantaneously. Provide a due date if you expect a response by a certain date. If the issue is non-urgent, you can choose to not provide a due date. But then you shouldn’t expect an instantaneous response either.

Share best practices that you’ve learned from other site coordinators that may help them

If you are an experienced clinical research professional, chances are that you’ve learned many best practices over the years. Sharing these best practices will inspire and engage site coordinators. Many coordinators would love to learn how other sites are maintaining clinical trial files, screening and consenting patients or preparing for an FDA audit. If you provide value to your site coordinator, they will do the same, if not more for you.

To summarize, in this post we’ve covered 10 smart strategies to getting response from clinical site coordinators.

Combine your requests

Offer to work directly with other departments such as legal or IT on specific tasks

Provide clinical research tools that actually help the site coordinator

Communicate regularly and do not surprise them with tight timelines

Commend study coordinators in front of his or her manager or site investigator

Be soft spoken, calm and professional at all times

Recognize gaps in the site coordinators skills, and use it as an educational opportunity

Determine the preferred communication frequency, method of communication and time of day

Be specific on when you need a response

Share best practices that you’ve learned from other CRCs that may help them

I hope you found much value from this post. If so, please share with a friend or leave a comment below.

]]>http://clinicaltrialpodcast.com/10-smart-strategies-getting-response-clinical-site-coordinators/feed/45 Ways To Get Clinical Research Associate Experiencehttp://clinicaltrialpodcast.com/5-ways-to-get-cra-experience/
http://clinicaltrialpodcast.com/5-ways-to-get-cra-experience/#commentsFri, 28 Oct 2016 05:01:26 +0000http://clinicaltrialpodcast.com/?p=214You are interested in get a job a clinical research associate. Employers are looking for “experienced” clinical research associates. You can’t get experience if no one is wanting to hire you for the role and people who are hiring are looking for individuals with experience. Given that there is no...

You are interested in get a job a clinical research associate. Employers are looking for “experienced” clinical research associates. You can’t get experience if no one is wanting to hire you for the role and people who are hiring are looking for individuals with experience. Given that there is no “clinical research” major at colleges and universities, it can be quite challenging to get academic experience as well.

In this post, I’ll share with you how you can get that clinical research experience employers are looking for.

Become a Volunteer at a Hospital or Clinic

Hospitals are looking for people to volunteer. As a volunteer, your job can be as simple as moving patients on the wheelchair from one medical unit to another, helping out with social media efforts, writing articles for the hospital website or working with the hospital medical director on an clinical research project.

Each of these roles offer you unique perspectives that are necessary to understand as a clinical research associate. For example, the simple job of moving patients gives you an opportunity to interact with patients. It teaches you to listen and be empathetic. Helping a the hospital with writing articles for the website, you can gain valuable writing experience that you can utilize to write your monitoring visit trip reports. Working with a medical director will give you first hand experience of what it takes to set-up a research project at the hospital. If you are lucky, you may have the opportunity to present results from your research paper in an academic journal or at a scientific conference.

A part-time volunteer work for 4-6 hours a week is generally sufficient. You can apply for these volunteer positions directly through the hospital administration or emailing medical directors directly to see if they have a research project they can use some free help with. When you volunteer, take your work seriously and show up at the scheduled date and time. After volunteering for 3-6 months, you should be a better position to talk to potential employers about your experience and how it can benefit them should they decide to hire you.

Invest in Learning

One of the fastest way to demonstrate that you are serious about becoming a clinical research associate is to invest in learning. You can read regulatory guidance documents on different topics pertaining to clinical research industry. Regulatory agencies around the world publish guidance documents on various topics on their website. For example, the FDA has guidance documents on risk-based monitoring. Alternatively you can take a clinical research certification course. When you are taking classes, try to find opportunities to get some practical experience on an actual clinical research project. The best way to learn about potential opportunities to talk to your instructors. They would have connections in the industry and would be usually happy to introduce you to other clinical research professionals. You would get course credit for the project and also get hands-on experience working on a real-life project.

Start Working A Clinical Research Assistant or Coordinator

One way to demonstrate understanding of the clinical research associate role is to work as a clinical research assistant. Clinical Research Organizations (CRO) or hospitals that participate in clinical trials can provide such opportunities. CROs are usually looking for individuals with little or no experience to take care of administrative tasks. Hospitals are looking for research coordinators to enroll clinical trial patients, perform chart review or clinical trial data entry. Over 6-12 months, you will gain deeper understanding of the clinical research associate position.

Create Clinical Research Content on the Internet

One creative ways to show that you have “experience” is to create videos on Youtube or write articles on LinkedIn on different topics related to clinical research associate. For example, you can read regulatory guidance documents and make interesting videos or write online articles to share your learning. The key here is to be consistently produce high quality content over a period of 3-6 months. When you speak with potential employers and tell them what you’ve done, they are guaranteed to be impressed.

If you are not from the US or don’t want to travel long distance, you can attend a local conference or meet-up. These conferences will jump start your know-how about clinical research. You can also network with other clinical research associates.

If you don’t have the funds to attend the conference, consider volunteering at one. The best part about volunteering is not the free ticket. You can list this volunteering experience on your resume.

Do you have other ideas on how to get clinical research experience? Or have feedback on this post? Please share in the comments section below.

]]>http://clinicaltrialpodcast.com/5-ways-to-get-cra-experience/feed/13 Reasons Why Your Project Is Behind Schedulehttp://clinicaltrialpodcast.com/3-reasons-why-your-project-is-behind-schedule/
http://clinicaltrialpodcast.com/3-reasons-why-your-project-is-behind-schedule/#commentsSun, 02 Oct 2016 22:16:45 +0000http://clinicaltrialpodcast.com/?p=188Whether you are a leading a project with a team that doesn’t report to you or a research manager leading a team of research coordinators, clinical research associates, biostatisticians, data managers or project managers, you’ve probably been in situations where work was not done as planned or expected. Deliverables don’t...

Whether you are a leading a project with a team that doesn’t report to you or a research manager leading a team of research coordinators, clinical research associates, biostatisticians, data managers or project managers, you’ve probably been in situations where work was not done as planned or expected.

Deliverables don’t get completed primarily due to (1) lack of clarity on the outcome expected, (2) inadequate amount of time allocated for the project or task or (3) a team member was procrastinating till the last minute.

Lack of clarity on the outcome expected

This situation is far more common that one would think. Project managers (including those that may have certifications behind their name) and senior managers sometime fail to provide clear direction to their team. Assuming the team has the right skills needed for the project, providing clarity on the expected outcome is a must.

Here are some tips on how to give and get clarity:

1. Get input from the people doing the work on your vision for a given task or project. For example, if you want to estimate how long it will take to write the clinical study report, you need to get input on the timeline and intermediate deliverables from medical writer, statistician and other individuals who will perform the activity.

2. Make yourself available to the team for questions, particularly during the early phases of the project. Developing a clinical strategy and ramping up clinical sites is hard work. Many people are involved and it is the leader’s responsibility to make herself available during the early project phases.

3. Respond to emails in 12-24 hours whenever possible. If you are slow on emails, your team will be slow too.

4. When a deliverable impacts more than one individual or team, be sure to get necessary alignment with everyone involved. Bigger the organization the more important this gets. Yes, this can slow you down – so you need to first decide whose input you absolutely need
Ask meaningful questions

Time allocated for the task was inadequate

Estimating how much time will be needed to complete a clinical research task or project can be a daunting exercise. Let’s take trial enrollment as an example. It is best to determine enrollment timeline based on data from literature or prior clinical trial experience. However such data is not always available, especially in the case of first generation medical products where previous trials have not been conducted. Also trial enrollment is highly dependent on the quality of centers, competitive clinical trials, and subject inclusion/ exclusion criteria. Given these variables, we don’t have precise information on how long it will take to enroll in a given clinical trial.

It therefore becomes important to understand the assumptions behind the projected timeline. If the assumptions no longer hold true, update the assumptions and the associated timeline.

A team member was procrastinating till the last minute

I’ve been a victim of procrastination. People usually don’t start working on projects that do not interest them, involve some sort of new learning or there is a fear of unknown.

With emotional intelligence, a leader can assess the project’s progress and identify any parts of the project that are not moving forward as expected. This is easier said than done because people are motivated by different things. Simply having an open, non-confrontational, one-on-one conversation with the individual can quickly resolve the situation.

The fear of unknown is a common problem with clinical trial managers. When a new clinical strategy is developed, people don’t know if the strategy will be accepted by the regulatory agency. Once the strategy is accepted, site start-up and enrollment can be slow due to external factors such as site contracts and competing clinical trials. We don’t know if a database lock will happen on or before schedule because this is highly dependent on the site and the patient returning for their follow-up visit. Lastly, after years of work, the medical product may not have the necessary safety and efficacy data needed to secure product approval.

Do you have any other reasons on why a clinical research project can be behind schedule? If so, please share in the comments section below.

]]>http://clinicaltrialpodcast.com/3-reasons-why-your-project-is-behind-schedule/feed/2Becoming A Wartime Generalhttp://clinicaltrialpodcast.com/becoming-a-wartime-general/
http://clinicaltrialpodcast.com/becoming-a-wartime-general/#respondFri, 26 Aug 2016 05:42:33 +0000http://clinicaltrialpodcast.com/?p=180When you are managing a clinical research project, you are bound to experience “good times” and “bad times”. Clinical research projects are always evolving. Somedays a project will be moving forward smoothly and on other days things might be quite challenging. Like anything in life, unexpected issues do come up....

When you are managing a clinical research project, you are bound to experience “good times” and “bad times”. Clinical research projects are always evolving. Somedays a project will be moving forward smoothly and on other days things might be quite challenging. Like anything in life, unexpected issues do come up. A Wartime General mindset can help you deal with things when the work is challenging.

In this post, I’ll share four ways on how to become a Wartime General.

Take Up Challenging Goals

Every organization or project has a big audacious goal that needs to be met. Such goals include getting product to market, finishing trial enrollment or passing a regulatory audit. No matter what your role is in the organization, you need to have a clear understanding of “the big goal”. If you don’t know, ask your colleagues, your manager or director. Think about how your work can help support the organization or project in achieving that goal.

The most important part of this exercise is being honest with yourself. It is easy to get sucked up in email or attend unnecessary meetings. You won’t realize that you’ve spent all day (or weeks or months) doing things that don’t help. We’ve all fallen prey to this at some point in the past.

Complete three tasks daily that are going to help your organization or project achieve that big audacious goal.

Consistently Show Up

There are so many people who don’t show-up. They may be physically present but choose not to actively participate in the dialogue. Being present, especially when the work is boring and monotonous is extremely important.

Ask probing questions, anticipate issues and take steps to resolve those issues. Delivering work on time is part of consistently showing up. Be seen as a dependable individual who is not afraid to produce work. Many people strive for perfection and this holds them back. In turn they don’t deliver and do not fully show up.

Provide Value To The People You Work With

Your personal brand should have a Unique Value Proposition (UVP). Always think what is it that you can do to create value for others. Clinical research associates can create value for their sites by being respectful of the research coordinator’s time, showing up on time for a monitoring visit, delivering on the promise that was made or simply being polite and courteous. If you work for a clinical research organization (CRO), you should always think about what value you can create for your sponsor. And if you are a sponsor, you can think about ways to provide value to your suppliers and physicians so they want to keep partnering with you in the future. If you create value for others, your UVP score goes up and this will eventually lead to the great professional successes you’ve always dreamed of.

Understand Data And Take Appropriate Action

If you are in a role where you reviewing or analyzing clinical trial data, you can become a wartime general by taking the time and effort to understand the root cause of high query rates or compliance issues. You can then use this information to educate your project team and your management and discuss solutions to address these issues.

For issues such as slow clinical trial enrollment issues, data on reasons for screen failure, competitor trial intelligence, or research team engagement on a medical product or trial design can serve as useful information to isolate key challenges preventing a project from reaching the milestones.

I hope you can apply on one or all of these strategies and how things work out for you in the comments section below.

]]>http://clinicaltrialpodcast.com/becoming-a-wartime-general/feed/0Crafting Perfect Emails to Physicianshttp://clinicaltrialpodcast.com/crafting-perfect-emails-to-physicians/
http://clinicaltrialpodcast.com/crafting-perfect-emails-to-physicians/#respondTue, 09 Aug 2016 00:28:17 +0000http://clinicaltrialpodcast.com/?p=148I have a confession to make. Back in 2007 when I joined Abbott Vascular as a Clinical Project Manager, I did not know to write emails. The core function of a project manager is being able to communicate well with all stakeholders. And here I was, afraid of typing and...

Back in 2007 when I joined Abbott Vascular as a Clinical Project Manager, I did not know to write emails. The core function of a project manager is being able to communicate well with all stakeholders. And here I was, afraid of typing and sending emails. I procrastinated for hours to perfect the wording of my email. It wasn’t that I was not familiar with the clinical trial space. I was just afraid and unsure on how to communicate effectively via emails.

My inspiration for this post is based my personal experience working with physicians – the site investigators that conduct clinical trials. I’ve also observed many clinical research associates and managers struggle when it comes to sending emails to physicians or at least don’t craft the email that will lead to a favorable or timely response.

One of the most important components of effectively managing clinical trials is physician communication. Crafting perfect emails to site investigators it’s an important skill all of us need to learn and hone.

In this post, I’ll share with you how I improved upon my email writing skills. We will discuss the process of writing a good email that will result in you getting a response you are looking for.

Write daily

Writing daily is a practice that pushes you to think creatively. Writing daily in your journal, blank piece of paper or a simple word document impacts the way we think and process information. When you write daily, you can write about anything that comes to your mind. Don’t try to correct spellings or control your thoughts. Just write. One website that makes it easier for you to write daily is 750 Words.

Observe how others are writing their emails

If you are already assigned to a project and communicating with clinical sites, observe the tone and structure of the emails. Physicians are busy people and will likely send one liner emails as a response to an email. Therefore they may not be the best person to emulate when you are starting off. Another great resource are emails from your team and your manager. The idea here is the you pick the best email practices that resonate with you and start implementing them right away. You don’t have to get this right from day 1.

Use bullets

This is my favorite tip. Using bullets breaks down information in easily understandable chunks of information. Bullets also help you frame your thoughts and make the process of writing an email much easier. The outcome is clearer emails. I see so many people write long paragraphs (sometimes just one long paragraph) about an issue or topic they are trying to communicate. This is a poor approach to writing emails – especially when writing to physicians who are busy individuals.

Have a call to action

What response do you expect from a physician when you send them an email? Is it just information you are trying to share or you to expect them to respond back to you with specific information. Be clear on the action you expect the physician to take. Also you can use bullets to write your call to action, especially if you have multiple items you need responses to.

Respectful, friendly and professional email tone

Growing up in India, we were always taught to respect physicians. We would address them as “Dr. Shah” and not by their first name. Although I see no issue with addressing physicians by their first name when you have a rapport with them. But if you don’t know the physician, it’s best to default to the “Dr.” or “Professor” salutation. In some countries, “Professor” is considered more appropriate and of higher importance than “Dr.” – so be sure to understand this nuance.

You also want to sound friendly and professional in your email. In other words, don’t sound demanding. Use words such as “please”, “kindly”, “thank you” in your emails. Almost always, I end my emails with “Thank you for your time and consideration” and it works like magic.

Pay attention to formating

It breaks my heart to see unformatted emails – unnecessary bolding of the text, highlighting in red, using upper case fonts, spelling and grammar errors and using different font types in one email reflects poorly on the email sender. It is also distracting to the reader. The most common email formatting error I’ve see if people copy-pasting emails or information from other documents into an email. When you copy information from one source into an email, use the “paste-special” feature to remove unnecessary formatting and ensure the content you are pasting matches the email format. You can also send a test email to yourself to verify if your email is correctly formatted. Making formating errors makes you and the company you represent look sloppy.

Understanding and implementing these email technique will help you achieve the email response you are looking for from physicians. Most importantly, don’t rely solely on email communication, especially for sensitive topics that require an in-person meeting or a phone call.

I hope you found much value from this post. I’d love hear any tricks or tips you have to share or any other thoughts on this post.